Regulatory Focus™ > News Articles > Regulatory Recon: Wockhardt's US Plant Cited by FDA (3 June 2014)

Regulatory Recon: Wockhardt's US Plant Cited by FDA (3 June 2014)

Posted 03 June 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Wockhardt's US Plant Cited by FDA (3 June 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • FDA catches Wockhardt U.S. plant using same spurious testing procedures as Indian plants (India Times) (Fierce) (WSJ-$) (Bloomberg)
  • The Ascension of FDA’s September 19, 2011 Marketed Unapproved Drugs Compliance Policy Guide (FDA Law Blog)
  • Chicago Accuses Drug Companies of Pushing Opioids (Bloomberg)
  • SOCMA slams expected 40% drop in FDA’s domestic API facility inspections (In-Pharma)
  • Humana files RICO suit against Medtronic over Infuse bone graft (Fierce) (Mass Device) (WSJ-$)

In Focus: International

  • World Health Assembly Strengthens Regulatory Standards (FDA)
  • As EU election dust settles, two pharma dossiers loom (SCRIP-$)
  • UK likes the look of EMA quicker approvals pilot (Pharma Times)
  • How PTC changed CHMP's mind on Translarna for DMD (BioCentury-$)
  • EMA Revises Biosimilars Guideline (EMA)
  • DCGI Plans Online Handling Of India Trial, Approval Processes (PharmAsia-$) (Business Standard)
  • DCGI suspends Ranbaxy’s supply (Asian Age)
  • Canada’s Health Committee to consider drug regulation bill Thursday (AllTrials)

US: Pharmaceuticals/Biotechnology

  • FDA catches Wockhardt U.S. plant using same spurious testing procedures as Indian plants (India Times) (Fierce) (WSJ-$) (Bloomberg)
  • The Ascension of FDA’s September 19, 2011 Marketed Unapproved Drugs Compliance Policy Guide (FDA Law Blog)
  • BioCentury TV Interview on the Energy and Commerce Committee's 21st Century Cures Initiative (BioCenturyTV)
  • Chicago Accuses Drug Companies of Pushing Opioids (Bloomberg)
  • SOCMA slams expected 40% drop in FDA’s domestic API facility inspections (In-Pharma)
  • BIO: Accelerated Approval Label Guide Sends Wrong Signal To Insurers, Could Affect Reimbursement (IHP-$)
  • FDA gives Prosensa's lead drug new path towards approval (Reuters) (The Street)
  • Eli Lilly gets on the trial transparency bandwagon (Fierce) (PMLive)
  • Review of rank-based procedures for multicenter clinical trials (PubMed)
  • Boehringer Ingelheim Announces Successful Resolution of FDA Warning Letter (Press)
  • Aurobindo gets USFDA nod to market mental illness drug (India Times)
  • Baxter Escapes Heparin Contamination lawsuit (Court)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • ASCO 2014: Boehringer lung cancer drug shows survival benefit (Pharmafile)
  • ASCO 2014: Amgen's T-VEC shows efficacy, but is it enough? (SCRIP-$)
  • ASCO 2014: Lilly's CYRAMZA Significantly Improves Overall Survival In Phase III NSCLC Study (Press)
  • ASCO 2014: Novartis bone marrow drug improves progression-free survival (Reuters)
  • AstraZeneca’s novel antibiotic candidate AZD0914 given Fast Track status by US FDA (Press)
  • ChemoCentryx's CCX168, an Orally Administered Complement C5a Receptor Inhibitor, Granted Orphan-Drug Designation in ANCA-Associated Diseases by the FDA (Press)
  • FDA Approves Spectral's Amended Protocol for its EUPHRATES Trial (Press)

US: Medical Devices

  • FDA's Initiative for Safe Design and Effective Use of Home Medical Equipment (PubMed)
  • Humana files RICO suit against Medtronic over Infuse bone graft (Fierce) (Mass Device) (WSJ-$)
  • FDA wants more data for Epigenomics' PMA (BioCentury)
  • Decontamination Of Reusable Devices After A Terrorist Attack Discussed At FDA Medical Countermeasures Event (Gray Sheet-$)
  • GE Healthcare Announces FDA Approval of Invenia Automated Breast Ultrasound System (ABUS) for Enhanced Patient Experience and More Accurate Diagnosis than Mammography Alone in Women with Dense Breasts (Press)
  • Nexus6 gets FDA clearance for smartphone-connected inhaler, SmartTouch (Mobi Health News)
  • Advanced Brain Monitoring Receives FDA Clearance for Night Shift Therapy – A Novel Treatment for Positional Obstructive Sleep Apnea (Press)

US: Assorted And Government

  • Profile of FDA Watchdog at GAO (WaPo)
  • The case for treating sugar like a drug (Vox)
  • High Court Clears Way For More Challenges To Vague Patents (Law 360-$) (Law 360-$)

Europe

  • As EU election dust settles, two pharma dossiers loom (SCRIP-$)
  • UK likes the look of EMA quicker approvals pilot (Pharma Times)
  • How PTC changed CHMP's mind on Translarna for DMD (BioCentury-$)
  • EDQM signs confidentiality agreement with TFDA (EDQM)
  • EGA calls for international regulatory cooperation (EGA)
  • EMA Revises Biosimilars Guideline (EMA)
  • EMA Guideline on Influenza Vaccines – Quality Module (EMA)
  • EMA Accepts HETLIOZ (tasimelteon) MAA for Non-24-Hour Sleep-Wake Disorder in the Totally Blind (Press)
  • Prepare now for new EU patent court, companies told (SCRIP-$)
  • Annual meeting of the National Pharmacopoeia Authorities of the European Pharmacopoeia (NPA) (EDQM)

India

  • DCGI Plans Online Handling Of India Trial, Approval Processes (PharmAsia-$) (Business Standard)
  • DCGI suspends Ranbaxy’s supply (Asian Age)
  • Maha FDA recommends uniform enforcement of rules in India to deliver quality drugs locally, overseas (PharmaBiz)
  • Gujarat FDCA wants CDSCO to clarify on proposed Rs.100 cr for upgrading regulatory system (PharmaBiz)

Canada

  • Canada’s Health Committee to consider drug regulation bill Thursday (AllTrials)
  • Hyperion Therapeutics Announces Health Canada Accepts RAVICTI(R) New Drug Submission With Priority Review (Press)
  • Sudden shortage of cancer medication means some hospitals pay up to 100 times more for the drug (Montreal Gazette)

Other International

  • World Health Assembly Strengthens Regulatory Standards (FDA)
  • Health software firms called to trial new international standard (Clinica-$)
  • Regulation, Reimbursement Notes From Indonesia (PharmAsia-$)

General Regulatory And Interesting Articles

  • Roche returns to antibiotic research as superbug threat grows (Reuters)
  • Researchers use 3-D printing to create synthetic blood vessels (Fierce)

Regulatory Reconnaissance #330 – 3 June 2014

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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